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Astra Zeneca announced on 12 January 2004 that it has launched its atypical antipsychotic quetiapine (Seroquel) in the UK for the treatment of manic episodes associated with bipolar disease.

The company also announced that the drug has received US FDA approval as a monotherapy and adjunctive therapy with lithium or divalproex for the short-term treatment of acute manic episodes associated with bipolar disorder. The approval was based on results from several registration trials.

Results from phase III monotherapy trials in patients with bipolar disorder showed that 77% of patients who responded to quetiapine achieved remission by day 21. The drug also reduced symptoms of agitation, hostility, and aggression that are sometimes associated with manic episodes. Quetiapine had a favorable side-effect profile.

In a separate double-blinded, multicenter, randomized, placebo-controlled phase III trial, 191 patients with bipolar disorder received quetiapine as an adjunctive therapy to lithium or divalproex in combination, or lithium or divalproex alone. Results showed that patients with bipolar disease and manic episodes treated with quetiapine as an adjunctive therapy to lithium or divalproex had a significantly greater response rate than patients treated with lithium or divalproex alone (54.3% versus 32.6%). The drug was well tolerated.

Quetiapine, a 5HT2 and dopamine D2 receptor antagonist, received EU approval for the indication of bipolar disease in October 2003, and is also approved in Mexico and New Zealand. The product is marketed worldwide for the treatment of schizophrenia.